Sanitary and sterile piping, and fluid transfer systems, are essential to many industries, particularly medical, pharmaceutical, biotechnology, etc. In transferring fluid products for further processing or storage, bulk fluid transfer pathways and connections must be established and maintained. These often involve the realignment or configuration of sanitary piping/tubing systems, which comprise multiple manual and automated valves, including the associated temperature and pressure transmitters, regulators, filters, steam traps, etc. Ensuring the required levels of sterility of the fluid transfer pathways in these systems is thus critical, and often problematic.
In more recent years, disposable specialized fluid transfer systems have been introduced which permit quick connections and disconnections of fluid transfer tubing or piping, most of which is formed of plastic. One such system for sterile processes employs a two-part connector known as the KLEENPAK™ HT Connector, available from Pall Corporation Life Sciences (see FIGS. 1A and 1B). This connector permits a dry connection to be made between two separate fluid pathways, while maintaining the sterile integrity of both. The connector consists of male and female portions, each portion having a vented peel-away strip that protects the port, or pathway opening, and maintains the sterility of the fluid pathways before the two portions are connected. The vented peel-away strips should be simultaneously removed immediately before the two connector portions are engaged to form a sealed, locked connection.
However, even with newer connection systems such as the KLEENPAK™ HT Connector, manual removal of the peel-away strips and positive engagement of the two connector portions is still required. The normally field-executed manual process provides an opportunity for operator variations, incomplete assembly of the male and female portions, sideways withdrawal of the vented strips, partial withdrawal of the vented strips, and incomplete insertion of the male portion into the female portion, all of which are detrimental to the operation of the connection assembly, and which can lead to the potential breach of sterile integrity. For example, if the vented strips are not simultaneously and evenly withdrawn from the male and female portions, there is the potential that the exposed, and potentially contaminated, outer surface of one of the vented strips may contact and contaminate the exposed port of the other connector portion. This possibility, and the potential harmful results which could follow, have led to careful scrutiny by various regulatory agencies.
What is needed, therefore, is a consistently repeatable and validated process which increases the likelihood of maintaining the required sterility.
Various features and aspects of the invention will become apparent upon review of the detailed description set forth below when taken in conjunction with the accompanying drawing figures, which are briefly described as follows.